Independent drug bulletins to promote the prescription of appropriate drugs: a necessary but difficult task
Bernard Burnand a
a. Institute of Social and Preventive Medicine, Lausanne University Hospital, 10 route de la Corniche, 1010 Lausanne, Switzerland.
Correspondence to Bernard Burnand (e-mail: Bernard.Burnand@chuv.ch).
Bulletin of the World Health Organization 2013;91:391-391A. doi: http://dx.doi.org/10.2471/BLT.13.122762
Drug treatments constitute a substantial portion of all health-care interventions. Despite their notable benefits, however, drug treatments are beyond the reach of sizable population groups and in some parts of the world there is little access to safe and effective medications even though new drugs are constantly being developed.
The effectiveness and safety of newly developed drugs are often viewed too optimistically.1,2 According to a Cochrane systematic review published recently, new drugs are seldom found to be substantially better than existing treatments.3 However, because of lack of full and transparent access to the protocols of many clinical trials, compounded by publication bias and selective reporting of their findings, the true effectiveness of many drugs remains unknown. It is a fact that the results of trials are more likely to be published if the findings are favourable than if they are not.4 In addition, some measured outcomes are never reported,5 which generally results in an overestimation of effectiveness and an underestimation of harmful effects. Thus, researchers and the public only come to know about those findings that are published and disclosed, and physicians prescribe treatments on the basis of this biased information. For all of these reasons, it is critically important that prescribing physicians have a source of information about drug effectiveness that is independent and as objective as possible.
Truly independent drug bulletins – those produced without financial or editorial intervention from the pharmaceutical industry, regulatory agencies and governments – are such a source.6 They make a contribution to society by objectively comparing the effectiveness of different drugs. Independent drug bulletins began to appear in the 1960s, after the thalidomide scandal. At the time the pharmaceutical industry was producing new drugs that were modifying health-care practices. In the 1970s, a group of physicians and pharmacists in France began to meet to discuss and prepare independent information about drugs for other physicians and pharmacists. The group, which came to be known as “Prescrire”, gained official recognition in 1980, when the French Minister of Health commissioned it to provide independent information to the drug authorities. The group was initially supported through government funding, but this was eventually suspended and its drug bulletin, Prescrire, has been fully independent since 1993.7 Prescire is an example of a truly independent drug bulletin. It publishes no advertisements and is financed solely through subscriptions and training courses for health-care professionals. Its readership, mainly physicians and pharmacists living in France, grew gradually until 2000, plateaued for several years, and jumped to about 35 000 in 2012 after the European Medicines Agency recommended the withdrawal of benfluorex.8 Prescrire is published in French, although some reports are available in English.
Prescrire’s articles and reports are the result of close collaboration among physicians and pharmacists. They are prepared by about 100 paid collaborators trained in the use of evidence-based approaches and have no individual authors. This 80-page, entertaining monthly bulletin contains reports, news and practical guidance. Each report is written by a main author and a co-author, who together conduct an exhaustive, systematic search of the information available on a given drug (i.e. published articles, reviews and guidelines, agency reports, reports obtained from pharmaceutical companies) and prepare a critical appraisal. After the co-authors and the editor in charge have reached agreement on a final draft, every report is reviewed by 15 to 40 internal and external peers before being revised and finalized by the authors and the bulletin’s editorial committee. Additional reports, including the annual financial statement, are available on the bulletin’s web site. Prescrire is influential in official drug-related decisions and daily drug use in France.
There is a definite place for independent drug bulletins.6 The International Society of Drug Bulletins lists 50 of these publications, mainly from Europe and South America.9 Regardless of the difficulty of relying solely on subscriptions to pay for the collaborators’ hard work, the model merits being widely reproduced. Yet despite their vital role, independent drug bulletins cannot begin to compensate for the lack of transparency in the reporting of clinical research.10 Of all the clinical trials that are conducted, only about half publish their results and those that yield positive findings are selectively published more often.11 This is inadmissible. Everything from the key components of the protocol to the full data set must be made available for public scrutiny. To achieve this goal, authorities as well as national and international agencies must be persuaded, through strong and persistent advocacy, to adopt and enforce measures mandating the transparency of the entire clinical research process.
The author thanks Pierre Chirac of “Prescrire” for the information he provided.
- Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008; 358: 252-60 http://dx.doi.org/10.1056/NEJMsa065779 pmid: 18199864.
- Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med 2008; 5: e217, discussion e217 http://dx.doi.org/10.1371/journal.pmed.0050217 pmid: 19067477.
- Djulbegovic B, Kumar A, Glasziou PP, Perera R, Reljic T, Dent L, et al., et al. New treatments compared to established treatments in randomized trials. Cochrane Database Syst Rev 2012; 10: MR000024 http://dx.doi.org/10.1002/14651858 pmid: 23076962.
- Gøtzsche PC. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials 2011; 12: 249 http://dx.doi.org/10.1186/1745-6215-12-249 pmid: 22112900.
- Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med 2009; 361: 1963-71 http://dx.doi.org/10.1056/NEJMsa0906126 pmid: 19907043.
- The future of independent drug bulletins. Drug Ther Bull 2012; 50: 61 http://dx.doi.org/10.1136/dtb.2012.06.0106 pmid: 22679242.
- Prescrire.org [Internet]. Prescrire. Paris: Prescrire; 2013. Available from: http://www.prescrire.org/fr/ [accessed 25 April 2013].
- Mullard A. Mediator scandal rocks French medical community. Lancet 2011; 377: 890-2 http://dx.doi.org/10.1016/S0140-6736(11)60334-6 pmid: 21409784.
- ISDB [Internet]. Paris: International Society of Drug Bulletins; 2013. Available from: www.isdbweb.org [accessed 25 April 2013].
- Gøtzsche PC. Deficiencies in proposed new EU regulation of clinical trials. BMJ 2012; 345: e8522 http://dx.doi.org/10.1136/bmj.e8522 pmid: 23258926.
- Song F, Bhurke SP, Hooper L, Loke YK, Ryder JJ, Sutton AJ, et al., et al. Extent of publication bias in different categories of research cohorts: a meta-analysis of empirical studies. BMC Med Res Methodol 2009; 9: 79.